Randomised Intervention Trial to Evaluate Single- and Double- Freeze Cryotherapy in the Prevention of Cervical Neoplasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- The primary end point is the cure rate at the end of one year
研究概览
简要总结
To evaluate whether single- and double-freeze cryotherapy techniques have similar efficacy in controlling different grades of cervical intraepithelial neoplasia (CIN), and have similar side effects and complications.
详细描述
Healthy women aged 25 to 64 yrs with histology confirmed ectocervical CIN lesions confined to ectocervix without extension to endocervix or vagina will be randomized to single- or double-freeze cryotherapy, as per the inclusion criteria will be invited to participate in the study.
They will be explained about the study. Informed consent will be obtained from each recruited woman. The cases selected with lesions that can be adequately covered with largest cryo probe (2.5 cm diameter) will be randomized between the following arms.
Arm 1 Single-freeze technique; 3 minutes of freeze and 5 minutes of thaw. Arm 2 Double-freeze technique: 3 minutes of freeze and 5 minutes of thaw and cycle repeated once again.
The patients will be advised about excessive discharge per vagina for 4 weeks and mild abdominal cramps.
They will be advised to abstain from sexual intercourse for 6 weeks. They would be followed up after one month for clinical evaluation and at 12th month to determine the cure rates by Pap test, HPV Test and colposcopy with or without biopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Apparently healthy women aged 25 to 64 yrs with following criteria will be eligible to participate in the study.
- •Histological confirmation of ASCUS -H, CIN I, CIN II and CIN III lesions.
- •The lesion confined to ecto cervix only.
- •No obvious cervical and vaginal infection.
- •Women in proliferative phase of menstrual cycle or post menopausal cases.
- •Negative endo cervical curettage.
排除标准
- •Women less than 25 and more than 64 years will not be enrolled.
研究组 & 干预措施
Single-freeze cryotherapy
Arm 1 Single-freeze technique; 3 minutes of freeze and 5 minutes of thaw.
干预措施: Cryotherapy (Procedure)
Double-freeze cryotherapy
Arm 2 Double-freeze technique: 3 minutes of freeze and 5 minutes of thaw and cycle repeated once again.
干预措施: Cryotherapy (Procedure)
结局指标
主要结局
The primary end point is the cure rate at the end of one year
时间窗: 1 year
The primary end point is the cure rate at the end of one year by comparing between two different techniques of cryotherapy i.e. single freeze and double freeze.
次要结局
- The secondary end points are the rates and the types of side effects and complications(1 year)
研究者
Gauravi Ashish Mishra
Associate professor Department of Preventive Oncology
Tata Memorial Hospital